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A little over a month ago, news that a bispecific antibody—ivonescimab, produced by Summit Therapeutics and Akeso—had performed well in a Phase 3 non-small cell lung cancer clinical trial, causing a big stir in the biotech community. Celebrated as a success for cancer immunotherapy, Keytruda, which was initially approved by the FDA in 2014 for the treatment of melanoma (and has since been used for the treatment of a host of other cancers), is well known. Luba Greenwood, J.D., the Managing Partner of the Dana Farber Cancer Institute Venture Fund, Binney Street Capital, captured the moment in Episode 103 of the Biotech Hangout podcast.  “I would say probably in the last two-three years there hasn’t been that much interest in investment, where people are turning up their nose,” and doubted the incumbent therapy could be surpassed, Greenwood said.   Greenwood then pointed the conversation toward patient needs and the value of new therapies, which is one of the drivers for our model, for knowing uncertainty in biotech development and investing wisely. Listen to the full podcast, which features also Daphne Zohar, Josh Schimmer, Yaron Werber, and Dawn Bell, PharmD.    Check it out here if you haven’t already: https://lnkd.in/g7R8te5r    #HEOR #Innovation #DrugPricing #BioPharma #HealthEconomics 

With the federal government aiming to set drug price ceilings in the Inflation Reduction Act, the need for a transparent, quantitative approach to determining value-based prices is more urgent than ever. Without one, innovators cannot predict what will happen next year, much less 15 years from now when their pipeline candidates might be subject to government price controls. QALYs, a controversial tool in standard cost-effectiveness analysis of the value of drug, have been at the center of heated scientific and policy debates in recent months. Medicare is prohibited from using them by the federal government as they discriminate against people with disabilities, and a more comprehensive ban has been making the rounds in Congress since February. In response, several prominent voices have argued that the QALY measure can be modified to correct its shortcomings and should not be banned altogether. Our CSO Darius Lakdawalla addresses the subtleties of this debate in an article published together with Jason Doctor in Health Affairs magazine. They argue that addressing only some of the issues with QALYs, such as removing the assumption that “sicker groups gain fewer QALYs from a fixed increase in life expectancy” doesn’t really help because there are other fundamental shortcomings in the model, including the assumption that “an additional QALY is worth the same to sicker and healthier groups.” As an alternative, they propose using the GRACE methodology, co-developed by Darius together with our Scientific Advisor Charles Phelps. Centered around patient preferences, GRACE avoids discrimination by accounting for the idea that people who are less healthy — e.g. those of very advanced age, with disabilities or severe illness — value health improvements more than those with more health. GRACE maintains a transparent, quantitative, and predictable approach to value assessment, while still addressing justifiable concerns about discrimination against our most vulnerable patients. Check out the full article, including a detailed analysis of the main assumptions behind the debate, here: https://lnkd.in/gp67An-6 #HEOR #Innovation #DrugPricing #BioPharma #HealthEconomics 

Health Economics needs to factor in the preventative value of treatments in order for the ongoing drug pricing negotiations to serve society best in the longer term, our Co-Founder and Scientific Advisor Dana P Goldman told a panel event hosted by The Hill.    “The way to save money in healthcare is to keep people out of the hospital,” Dana said. “That's what drugs do when they work best. They keep people out of the hospital. And we are negotiating those prices at the same time we are not solving these preventive healthcare issues that will drive disparities and costs.” For a good example of this dynamic, check out Dana’s blog about Medicare coverage of new obesity treatments: https://lnkd.in/gCTbB2aZ #HEOR #Innovation #DrugPricing #BioPharma #HealthEconomics 

A nice summary from Jason Shafrin on the increasingly persuasive case for lower discount rates in HTA.

 Patrick N. of Affinity Asset Advisors was asked if the end of 2023 were allegedly the best months in biotech history.  “It was a painful preceding few years,” he said. “It feels like the time is probably around now when we start to see people becoming more interested in the sector again. It’s exciting as a biotech investor. Obviously, these companies are going to help people down the road, and they need to be able to raise money to do that, and hopefully with a better market environment that can happen.” Key to long-term success is the ability to accurately model uncertainty. This is why we created our advanced digital PROVEN ™ platform. Check out the full interview with Nosker (part of the SF Healthcare Week conference) here: https://lnkd.in/g8ad4zNV  #HEOR #Innovation #BioPharma #HealthEconomics 

The connection between music and medicine goes back millennia—at least to the Greeks who used musical instruments to try to heal patients. Recently, musician and life sciences investor D.A. Wallach opened up to Endpoints News about his own experience in both worlds. “I think there is sometimes a similarity in the personality type of musicians and scientists,” Wallach said. “It is not a perfect overlap, but there’s a combination of detail-orientation and free-spiritedness that I sometimes recognize in folks who thrive in these worlds. One needs to have an impulse to explore in open-ended spaces and to combine ideas in novel ways in order to generate new materials, and then discipline and obsessiveness are required to take you from there to something tangible.” This interview resonates with our vision in more than one way. Health economics is as much a science as an art, and fine-tuning the right methodology to give a tangible expression to the intangible requires those same qualities and skills. Beyond that, we created our cutting-edge PROVEN ™ platform to help scientists and investors understand better the uncertainty associated with business planning in the life sciences—and in this way to more efficiently enable the kind of innovation Wallach is passionate about.  Read the full interview here: https://lnkd.in/gAnNXQHi #HEOR #Innovation #BioPharma #HealthEconomics 

Pharmaceutical Executive cited Darius Lakdawalla in its coverage of the Financial Times US Pharma and Biotech Summit 2024. “It'll take probably five or 10 years to play out on the negotiation side,” Darius said, “which is really more price setting than it is negotiation. There is a lot of question about what CMS is going to do to set prices. And they've been pretty vague about how they're going to do that in order to preserve flexibility and discretion. In fact, I think it's clear that the guidance that they issued for this year's price saying they're not going to hold themselves to in future years. So even if you look at if you look at what happens in the fall, you're not going to get a lot of insight into what's going to happen in the following years. So that's part of the uncertainty. Then there's also a market level uncertainty, which is because of the inflation boundaries that, in some ways, probably pose the most pivotal risk for the industry. The question is, how is that going to be handled? So now there's asymmetric risk when you set your launch prices. If you set your launch price too low, there's not really a way out.” The PROVEN Platform is where Darius and the team have been working out how the value of medicine is being understood and misunderstood through these changes. Please let us know if you would like to see PROVEN yourself. Read the full article here: https://lnkd.in/gh67kFbu  #HEOR #Innovation #DrugPricing #BioPharma #HealthEconomics

The impact of the Inflation Reduction Act and the unprecedented drug price negotiations in the US on biotech investing was a major topic at the Financial Times US Pharma and Biotech Summit 2024 in New York. Darius Lakdawalla was joined by Johanna (Rodriguez) Grossman, PhD at NYSE, Harmeet Dhillon at GSK, Amit Sinha at Goldman Sachs on the panel, Soft Landing, Hard Problems. Oliver Barnes, US pharma and biotech correspondent for the Financial Times moderated. The stakes involved in getting launch prices right have never been higher, Darius shared. In the future, it will be harder to compensate for low initial prices with annual price hikes while setting the launch prices too high can result in access limitations. Despite that there are multiple strategies to sustain medical innovation through current market volatility. Darius pointed to dynamic pricing models and better recognizing the social value of innovation in healthcare economic models. These all hinge on modeling uncertainty accurately. The recently released PROVEN platform is the engine Darius and his team are using to accelerate analysis on this, test current thinking and refine our understanding of how pricing works and how to plan for a changing environment. The full video from the summit can be purchased from the event organizers here: https://lnkd.in/ebXx2jk #HEOR #Innovation #DrugPricing #BioPharma #HealthEconomics

When the year started biotech investors had a smaller appetite for risk compared to previous years. Startups have needed to show a good business plan in addition to sound science to get funded. These were key takeaways from this year’s BIO CEO & Investor Conference that took place in New York on February 26. How is that playing out now in May? “There’s the science, and I love the science, but I have been forced to think about the business a lot more over the last two years,” Ellen Hukkelhoven, Head of Biotechnology Investments at Perceptive Advisors, told the conference. “The drug needs to work, it needs to get approved—which is a separate question—and then it needs to sell. Even in preclinical companies, we are thinking about all three of those stages when we invest.” While startups have come up with various strategies to stand out to investors, including offering a preview of their data to their top targets, nothing beats solid economic analysis. This is why we created our advanced PROVEN ™ platform — to help both investors and biotech innovators model uncertainty and predict the value of novel therapies with unprecedented flexibility and precision. #HEOR #DrugPricing #BioPharma #Innovation Link: https://lnkd.in/gW4YUd33

Following ISPOR 2024, we're re-listening to Bioverge Ventures’ founder Neil Littman sharing VC insights into healthcare and the life sciences on Dr. Chris Stout’s Living a Life in Full podcast. “What was once deemed to be science fiction is now increasingly becoming science fact,” he said. “I firmly believe the next great revolution will be in the tools to re-architect our biology, our brains, our chemistry and ourselves. We are already seeing this play out in real time.” A key step along the way is to democratize access for a wider circle of investors to promising biotech deals, and to identify early on those startups which have the potential to contribute the most to patient needs. In order to select the latter, meticulous research and due diligence are paramount. "If I am intellectually honest, I have no idea a priori which one of our portfolio companies is going to have a billion-dollar outcome, but I need to have a relentless focus on the process to ensure we are investing in the right types of companies to give ourselves that statistical probability of success,” Littman added. We created our AI-powered PROVEN platform to help innovators as well as investors model uncertainty with unprecedented accuracy and flexibility and to gauge the value of any potential future treatment. To learn more about our innovative methodology, do not hesitate to reach out. Check out the full podcast here for more insights, including tips how to best manage the potentially complex relationship between VC investors and biotech founders, and a valuable perspective into how an investor’s well-curated network can contribute in diverse ways to the success of an early stage company: https://lnkd.in/dMPF7TSm  #HEOR #DrugPricing #BioPharma #Innovation